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Device Classification Under Section 513(f)(2)(De Novo)
Details: Device Classification Under Section 513(f)(2)(De Novo) FDA Home; Medical Devices; Databases - 231 to 240 of 336 results Decision Date To: 07/06/2022
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Device Classification Under Section 513(f)(2)(De Novo)
Details: Device Classification Under Section 513(f)(2)(De Novo) FDA Home; Medical Devices; Databases - 161 to 170 of 336 results Decision Date To: 07/06/2022
› Verified 7 days ago
› Url: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?start_search=161&productcode=&knumber=&denknumber=&applicant=&devicename=&type=&expeditedreview=&decisiondateto=07%2F06%2F2022&denovo=&sortcolumn=applicantdesc Go Now
Device Classification Under Section 513(f)(2)(De Novo)
Details: Device Classification Under Section 513(f)(2)(De Novo) FDA Home; Medical Devices; Databases - 261 to 270 of 336 results Decision Date To: 07/06/2022
› Verified 7 days ago
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Approved Risk Evaluation and Mitigation Strategies (REMS)
Details: The goal of the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program is to mitigate the risk of heart failure due to systolic dysfunction. Objectives: Monitor for detection of heart failure due to systolic dysfunction with periodic echocardiograms. Screen for drug interactions prior to each dispense. To become certified to prescribe.
› Verified 8 days ago
› Url: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=413 Go Now
Patient Information for the Impella 2
Details: Patient Booklet for P140003. Patient Information for the Impella® 2.5 . A Guide for You, Your Family and Caregivers . Federal Law (USA) restricts this …
› Verified 9 days ago
› Url: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003d.pdf Go Now
510(k) Premarket Notification
Details: Page Last Updated: 07/04/2022. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language
› Verified 3 days ago
› Url: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&ProductCode=JJE&KNumber=&Applicant=ROCHE%20DIAGNOSTICS&DeviceName=&Type=&ClinicalTrials=&DecisionDateTo=07%2F06%2F2022&Redact510K=&CombinationProducts=&ZNumber=&sortcolumn=kn_desc Go Now
510(k) Premarket Notification
Details: 1 to 10 of 77 Results ProductCode: LLZ Applicant: PHILIPS MEDICAL SYSTEMS Decision Date To: 07/06/2022
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Micra™ Transcatheter Pacemaker
Details: 6 Shaping a positive attitude about life with your heart device 66 Dealing with anxiety and getting the support you need 67 Medical care 68 Planning for an emergency 69
› Verified 9 days ago
› Url: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150033c.pdf Go Now
FDA Drug Shortages
Details: U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA
› Verified 3 days ago
› Url: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Iohexol%20(Omnipaque%20)%20Injection&st=c Go Now
Device Classification Under Section 513(f)(2)(De Novo)
Details: Device Classification Under Section 513(f)(2)(De Novo) FDA Home; Medical Devices; Databases - 131 to 140 of 336 results Decision Date To: 07/06/2022
› Verified 7 days ago
› Url: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?start_search=131&productcode=&knumber=&denknumber=&applicant=&devicename=&type=&expeditedreview=&decisiondateto=07%2F06%2F2022&denovo=&sortcolumn=applicantdesc Go Now
Ivy Wang Technical Manager 14th Floor, 1500# Central …
Details: U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.33 Silver Spring, MD 20993 www.fda.gov May 12, 2022
› Verified 8 days ago
› Url: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220740.pdf Go Now
Device Classification Under Section 513(f)(2)(De Novo)
Details: Device Classification Under Section 513(f)(2)(De Novo) FDA Home; Medical Devices; Databases - 181 to 190 of 336 results Decision Date To: 07/06/2022
› Verified 4 days ago
› Url: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?start_search=181&productcode=&knumber=&denknumber=&applicant=&devicename=&type=&expeditedreview=&decisiondateto=07%2F06%2F2022&denovo=&sortcolumn=devicename Go Now
Device Classification Under Section 513(f)(2)(De Novo)
Details: Device Classification Under Section 513(f)(2)(De Novo) FDA Home; Medical Devices; Databases - 171 to 180 of 336 results Decision Date To: 07/06/2022
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Patient Information FOSAMAX® (alendronate sodium) Tablets
Details: 4 • Drink alcohol often • Take bone thinning medicines (like prednisone or other corticosteroids) for a long time What can I do to help prevent or treat osteoporosis?
› Verified 7 days ago
› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr030,21575slr002_fosamax_lbl.pdf Go Now
Premarket Approval (PMA)
Details: axsym free psa: Abbott Laboratories: P980007 : 02/05/2004: architect anti-hcv assay; architect anti-hcv calib: ABBOTT LABORATORIES INC: P050042 : 06/07/2006
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Patient INSTRUCTIONS FOR USE Neulasta Onpro (nu-las-tah) …
Details: Important Information Wearing the On-body Injector . This on -body injector delivers Neulasta with an underthe skin (subcutaneous) injection. The on -body injector is small, for one time use, lightweight, batterypowered, and
› Verified 5 days ago
› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s201lbl.pdf Go Now
MEDICATION GUIDE WELLBUTRIN XL® (WELL byu-trin) …
Details: NDA 021515/S-025 Page 6 Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking.
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› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021515s025MedGuide.pdf Go Now
PATIENT INFORMATION ELOXATIN (OXALIplatin for injection) …
Details: NDA 21-492/S-006 NDA 21-759/S-001 Page 8 How can I reduce the side effects caused by cold temperatures? Cover yourself with a blanket while you are getting your ELOXATIN infusion. Do not breathe deeply when exposed to cold air. Wear warm clothing in cold weather at all times. Cover your mouth and nose with a
› Verified 6 days ago
› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021759s001,021492s006lbl.pdf Go Now
Seroquel Medication Guide
Details: 2 • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled.
› Verified 4 days ago
› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s055MG.pdf Go Now
Rx Only REMICADE (infliximab) Patient Information Sheet …
Details: 28 fever, feel very tired, have a cough, or have flu-like symptoms, these could be signs that you may be getting an infection. If you have any of these symptoms while you are taking or after
› Verified 6 days ago
› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073ppi.pdf Go Now
Medication Guide Victoza (liraglutide [rDNA origin]) Injection
Details: have any of the conditions listed in the section “What is the most important information I should know about Victoza?” are allergic to liraglutide or any of the other ingredients in Victoza.
› Verified 2 days ago
› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013mg.pdf Go Now
Patient Instructions for Use Aranesp (Air-uh-nesp) …
Details: 2. Use each Aranesp prefilled syringe only one time. 3. Do not shake Aranesp. 4. Gather the other supplies you will need for your injection (prefilled syringe with a transparent [clear]
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› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5197AranespPIUSyringe.pdf Go Now
Patient Information for Novolin 70/30 NOVOLIN 100
Details: This leaflet summarizes the most important information about Novolin® 70/30. If you would like more information about Novolin® 70/30 or diabetes, talk with your healthcare provider. For more information, call 1-800-727-6500 or visit www.novonordisk-us.com.
› Verified 5 days ago
› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019991s074lbl.pdf Go Now
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